APO-MOXIFLOXACIN TABLET

国: カナダ

言語: 英語

ソース: Health Canada

即購入

ダウンロード 製品の特徴 (SPC)
31-08-2020

有効成分:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

から入手可能:

APOTEX INC

ATCコード:

J01MA14

INN(国際名):

MOXIFLOXACIN

投薬量:

400MG

医薬品形態:

TABLET

構図:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

QUINOLONES

製品概要:

Active ingredient group (AIG) number: 0142242001; AHFS:

認証ステータス:

APPROVED

承認日:

2016-01-07

製品の特徴

                                Page 1 of 66
PRODUCT MONOGRAPH
PR
APO-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin (as moxifloxacin hydrochloride)
House Standard
Antibacterial Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
CANADA
Date of Revision:
August 31, 2020
SUBMISSION CONTROL NO: 240946
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
6
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
........................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
22
STORAGE AND STABILITY
.................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION .......................................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................
                                
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